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An Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234AM2) - NCT00770315-14618A(Clinical Trial 531267)



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City:  Rochester
State:  
NY
Zip Code: 14618
Conditions: Rhinitis - Allergic Conjunctivitis
Purpose: This study will evaluate the efficacy and long-term safety of ragweed sublingual tablet compared with placebo in subjects with ragweed-induced rhinoconjunctivitis.
Study summary:
Criteria: Inclusion Criteria: - Must be 18 to 50 years of age, of either sex, and any race. - Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous RS. - Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit. - Must be positive for specific IgE against Ambrosia artemisiifolia at Screening Visit. - Must have an FEV1 of at least 70% of predicted at Screening Visit. - Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor - Must be willing to give written informed consent and be able to adhere to dose and visit schedules. - Female subjects of childbearing potential must be using a medically acceptable and adequate form of birth control. These include: - hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable); - medically prescribed intra-uterine device; - medically prescribed topically-applied transdermal contraceptive patch; - double-barrier method (eg, condom in combination with a spermicide). - Female subjects of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female subjects who are not currently sexually active must agree and consent to use one of the above-mentioned methods if she becomes sexually active during the study. - Female subjects of childbearing potential must have a negative urine pregnancy test at Screening Visit. Women who have been surgically sterilized or at least 1 year postmenopausal are not considered to be of childbearing potential. Exclusion Criteria: - clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the RS. - clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed. - receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms). - clinical history of severe asthma. - asthma requiring medium or high dose ICS. - history of anaphylaxis with cardiorespiratory symptoms. - history of chronic urticaria and angioedema. - clinical history of chronic sinusitis 2 years prior to the Screening Visit. - current severe atopic dermatitis. - breast-feeding, pregnancy, or intending to become pregnant. - had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit. - history of allergy, hypersensitivity or intolerance to the ingredients of the IMPs (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine. - any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. - use of any investigational drugs within 30 days of Screening Visit. - participation in any other clinical study. - being a family member of the study staff. - inability to meet medication washout requirements. - unlikely to be able to complete the trial, or likely to travel for an extended time during the RS. - clinically significant abnormal vital sign or lab value. - participation in this same study at another site. - randomized into this study more than once. - inability to or will not comply with the use of self-injectable epinephrine. - greater risk of developing adverse reactions after epinephrine administration. - history of self-injectable epinephrine use
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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